ADA: FDA Unlikely to Zap Pioglitazone

SAN DIEGO -- Bladder cancer risks aren't likely to send the diabetes drug pioglitazone (Actos) down the same path as rosiglitazone (Avandia), according to this exclusive InFocus report from the American Diabetes Association meeting.

Earlier this month French and German regulators halted sales of pioglitazone over excess bladder cancer seen in a French epidemiologic study, which the FDA followed with a warning pending further review of the data.

Yet the situation may not be as dire as the cardiovascular risks that led the European Medicines Agency to take rosiglitazone off the market last year and the FDA to severely restrict access to it, as leading diabetes specialist John Buse, MD, PhD, explains in an interview with MedPage Today Senior Staff Writer Crystal Phend.

"I don't think it [pioglitazone] will be taken off the market in the United States," says Buse, director of the Diabetes Care Center at the University of North Carolina at Chapel Hill and a past president of the ADA.

The same kinds of studies that suggested an increase in bladder cancer showed a decrease in other more common types of cancers, he notes.

Pioglitazone also holds some unique benefits among anti-diabetic treatments that may argue for a clinical need to keep the drug on the market, Buse adds.

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